TECNIS ODYSSEY IOL DRN00V (REF DRN00V0175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474810716), received between Aug 8, 2024 and Aug 18, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Material Fragmentation; Mechanical Jam

  Patient problems: Eye Pain; Hyphema

  MAUDE report 50303725 ↗
• MalfunctionApr 7, 2026Break; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SCRATCH IN THE OPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) AFTER IMPLANTATION IN THE PATIENT'S LEFT EYE (OS). THERE WAS NO IMPACT TO THE PATIENT. THE DEVICE WAS PREPARED WITH OPHTHALMIC VISCOELASTIC DEVICE (OVD) FROM A DIFFERENT MANUFACTURER AT ROOM TEMPERATURE VIA THE HYDRATION PORT, BY THE NURSE. THE ACCOUNT ALSO REPORTED THAT THEY FELT MORE RESISTANCE THAN USUAL DURING PLUNGER ADVANCEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811596 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO VISUAL ISSUES THAT WAS DESCRIBED AS "LIGHT HALOS, NIGHT DRIVING". THE ISSUES WAS IDENTIFIED DURING A POST-OP SITE VISIT. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. IT IS UNKNOWN IF ANY MEDICATION WAS PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE OR ANY DELAY IN THE PROCEDURE. DIRECTIONS FOR USE WAS FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 24099543 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED A PLANNED EXPLANT OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) TO BE REPLACED WITH A DCB00 LENS AS PATIENT EXPERIENCED DECREASED VISION, HALOS, NAUSEA, AND SIGNIFICANT POSITIVE DYSPHOTOPSIA. THE SYMPTOMS AFFECTED PATIENT'S DAILY ACTIVITIES SUCH AS WALKING, READING, AND COMPUTER USE. THE IOL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE. THERE WAS INCISION ENLARGEMENT, BUT NO SURGICAL DELAY, VITRECTOMY, OR SUTURES WERE REQUIRED. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATIONS BEYOND THE STANDARD OF CARE WERE NECESSARY. THE PATIENT¿S PRE-OPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) WAS 20/50-1; POST-OPERATIVE BSCVA WAS 20/40-1 (ECCENTRIC). THE PATIENT OUTCOME WAS REPORTED AS TEMPORARY IMPAIRMENT. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Nausea

  MAUDE report 23874013 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT WHILE INSERTING THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, IT WAS NOTICED THAT THE TRAILING HAPTIC WAS BENT AND WAS UNABLE TO BE IMPLANTED. THERE WAS PATIENT CONTACT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS OKAY. IT WAS NOTED THAT THE LENS WAS NOT STUCK IN THE CARTRIDGE AND THE ISSUE WAS SEEN BEFORE ¿LOADING¿. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535343 ↗
• InjurySep 2, 2025Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE ORIGINAL SURGERY WAS PERFORMED TO CORRECT NARROW ANGLE GLAUCOMA, ASTIGMATISM, AND CATARACTS. POST-OPERATIVELY, THE PATIENT IS REPORTING SEVERE HALOS, THAT INTERFERE WITH HIS READING AND DRIVING. BOTH INDOOR AND OUTDOOR LIGHTING ARE AFFECTED. THE PATIENT WAS ABLE TO ADJUST THE LIGHTING ON HIS COMPUTER AND PHONE BUT, NOTHING ELSE CAN CHANGE THE HALOS. THE ISSUES STARTED IMMEDIATELY POST SURGERY WITH THE FIRST EYE AND BECAME WORSE AFTER THE SECOND EYE WAS COMPLETED. HE NOW NEEDS TO WEAR GLASSES AND THE DOCTOR INFORMED HIM HE WOULD HAVE 20/20 VISION AFTERWARDS AND WAS NOT PROVIDED IOL INSTRUCTIONS FOR USE (IFU) PRIOR TO THE SURGERY. PATIENT WAS INFORMED NOT TO DO AN EXCHANGE AFTER REPORTING ISSUES TO THE DOCTOR AND NOTHING FURTHER CAN BE DONE. HE WAS PROVIDED EXERCISES OF SITTING AND WATCHING THE TRAFFIC LIGHTS TO HELP TRAIN HIS BRAIN. HOWEVER, THE EXERCISES GIVES HIM A HEADACHE AND NOTHING MORE. YTTRIUM ALUMINUM GARNET (YAG) PROCEDURES WERE PERFORMED FOR CLOUDINESS/DISCOLORATION IN THE BACK OF THE EYE ON (B)(6) 2025 AND (B)(6) 2025. AN EYELID PROCEDURE WAS PERFORMED (B)(6) 2025 TO AS

  Patient problems: Halo; Posterior Capsule Opacification

  MAUDE report 22948142 ↗
• MalfunctionMay 27, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE. IT WAS NOTICED THAT THE IOL HAD A SCRATCH ON THE CORNER OF THE OPTIC. THE SCRATCH CAUSED RESISTANCE WHILE IMPLANTING IT. THE IOL REMAINS IMPLANTED BECAUSE THE DOCTOR FELT IT MAY NOT AFFECT THE PATIENT'S VISION. THERE WERE NO FURTHER COMPLICATIONS OR INJURIES SUCH AS A SIGNIFICANT DELAY, CAPSULE TEAR, VITRECTOMY, SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. PREOPERATIVE AND BEST CORRECTED VISUAL ACUITY IS SC (WITHOUT CORRECTION) : 20/50 PH (PINHOLE OCULAR): 20/30 AR:20/60 (AR: AUTOREFRACTOR) PREOPERATIVE UNCORRECTED AND BEST CORRECTED VISUAL ACUITY?: SC (WITHOUT CORRECTION) 20/40. THE PATIENT HAS BEEN SCHEDULED FOR A ONE MONTH POSTOPERATIVE VISIT AT WHICH POINT THEIR BEST CORRECTED VISUAL ACUITY WILL BE CHECKED AGAIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Posterior Capsule Opacification

  MAUDE report 22092435 ↗
• MalfunctionMay 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PRE-LOADED DRN00V MODEL INTRAOCULAR LENS (IOL) TORE AFTER BEING FULLY IMPLANTED IN THE PATIENT'S EYE. THE IOL WAS CUT IN HALF AND REMOVED DURING THE SAME PROCEDURE, A BACK-UP LENS WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE), AND THE CASE PROCEEDED AS PLANNED. THERE WAS NO MEDICAL INTERVENTION, NO PATIENT INJURY, AND NO SURGICAL INTERVENTION. PATIENT STATUS POST PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006752 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A DRN00V (TECNIS ODYSSEY WITH SIMPLICITY DELIVERY SYSTEM INTRAOCULAR LENS {IOL}) WAS EXPLANTED DUE TO AN UNSPECIFIED ISSUE. THE LENS WAS REPLACED WITH A LIGHT ADJUSTABLE LENS (LAL) LENS. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT PERTAINS TO PATIENT'S LEFT EYE. ANOTHER REPORT WILL BE SUBMITTED FOR PATIENT'S RIGHT EYE.

  Patient problems: Eye Injury

  MAUDE report 21875028 ↗
• MalfunctionMar 25, 2025Break; Failure to Advance; Material Split, Cut or Torn; Break; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WAS NOT DEPLOYED DUE TO A HOLE OR PARTIAL TEAR IN THE LENS. THIS ISSUE WAS IDENTIFIED DURING HANDLING. THERE WAS NO PATIENT CONTACT. A BACKUP LENS WAS USED IMMEDIATELY WITHOUT ANY ISSUES. ADDITIONAL INFORMATION REVEALED THAT THE PLUNGER HAD PUSHED THROUGH THE MIDDLE OF THE LENS. THE PATIENT IS DOING GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690226 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT REPORTED VISUAL DISTORTIONS THAT DID NOT IMPROVE WITH MANIFEST PRESCRIPTION (RX) BEYOND 20/40. THEIR PRE-OPERATIVE VISION WAS 20/200. THE REPORTED ISSUES WERE NOTICED DURING A POST-OP EXAM. THE PATIENT¿S OUTCOME WAS REPORTED AS PERMANENTLY IMPAIRED AND SIGNIFICANTLY AFFECTING THEIR DAILY ACTIVITIES. THEREFORE, THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. STANDARD MEDICATIONS WERE PROVIDED TO THE PATIENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 21553813 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CATARACT SURGERY AND POST TREATMENT WAS UNHAPPY WITH THE SHARPNESS AND QUALITY OF HER DISTANCE VISION AND FELT UNABLE TO SEE FINE PRINT FROM 60-30CM. PATIENT REPORTED POST-OP LONGSTANDING HISTORY OF DRY EYE ISSUES DESPITE NO PRE-OP DOCUMENTATION OF IT AND EXCELLENT PRE-OP ITRACE ABERROMETRY ANALYSIS. THERE WAS NO ISSUE WITH THE LENS AND NO USE ERROR. LENS WAS EXPLANTED. THE PATIENT WAS TEMPORARILY IMPAIRED. THE BSCVA PRE-OP WAS: 20/40 AND THE BSCVA POST-OP WAS: 20/30 AFTER THE ODYSSEY EXPLANT, A MONOFOCAL LENS WAS USED. POST MONOFOCAL IMPLANTATION THERE WAS SIGNIFICANT IMPROVEMENT IN THE PATIENT¿S PERCEPTION IN THE QUALITY OF VISION AT DISTANCE. PATIENT IS AN AVID FLY FISHERWOMAN AND WAS UNABLE TO TIE FLY FISHING LURES WITH THE ORIGINAL ODYSSEY IOL LENS BUT IS VERY PLEASED WITH THE IOL EXCHANGE AND CATCHING LOTS OF FISH ON HER FISHING TRIP; USES OVER THE COUNTER READERS TO TIE HER FISHING LURES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 19945857 ↗